SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer

July 10, 2026 updated by: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

A Phase II Clinical Study to Evaluate Sacituzumab Tirumotecan (SKB264) in Combination With SKB118 for the Treatment of Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yan Qing Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
  • Phone Number: 028-67255480
  • Email: qingyan@kelun.com

Study Locations

  • China
      • Jilin City, China
        • Jilin Cancer Hospital
        • Contact:
      • Shanghai, China
        • Shanghai East Hospital, Tongji University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC
  • Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.
  • Provide a tumor tissue sample.
  • At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
  • ECOG performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks.
  • Adequate bone marrow, liver, kidney, and coagulation function.
  • Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.

Exclusion Criteria:

  • Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
  • Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS).
  • Uncontrolled systemic disease as judged by the investigator.
  • Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.
  • Presence of other moderate to severe lung disorders.
  • History of haemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks.
  • Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.
  • Active hepatitis b or hepatitis c or co-infection with HBV and HCV.
  • Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
  • Known hypersensitivity to the study drug or any of its components.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SKB264 in combination with SKB118
SKB264 at 4 mg/kg combined with SKB118 at 3 mg/kg, 10 mg/kg, 20 mg/kg, or other dose levels
Drug: SKB264+SKB118
Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame: From enrollment to the end of treatment at 24 months
adverse events (AEs) and serious adverse events (SAEs), dose-limiting toxicities (DLTs), clinically significant abnormal laboratory results, etc.
From enrollment to the end of treatment at 24 months
ORR(objective response rate)
Time Frame: From enrollment to the end of treatment at 24 months
ORR as assessed by the investigator based on RECIST v1.1
From enrollment to the end of treatment at 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCR(Disease control rate )
Time Frame: From enrollment to the end of treatment at 24 months
as assessed by the investigator based on RECIST v1.1
From enrollment to the end of treatment at 24 months
DOR(duration of response )
Time Frame: From enrollment to the end of treatment at 24 months
as assessed by the investigator based on RECIST v1.1
From enrollment to the end of treatment at 24 months
PFS(progression-free survival)
Time Frame: From enrollment to the end of treatment at 24 months
as assessed by the investigator based on RECIST v1.1
From enrollment to the end of treatment at 24 months
OS (overall survival)
Time Frame: From enrollment to the end of treatment at 24 months
From enrollment to the end of treatment at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SKB264-II-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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